On December 5, 2020 Rhizen Pharmaceuticals, a clinical-stage oncology-focussed biopharmaceutical company, reported presentation of the interim results of a Phase I/II combination study of Tenalisib with Romidepsin for relapsed/refractory T-Cell Lymphoma patients at the upcoming 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting and exposition, to be held virtually from December 5 – 8, 2020 (Press release, Rhizen Pharmaceuticals, DEC 5, 2020, View Source [SID1234572242]).
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The poster presentation at ASH (Free ASH Whitepaper), 2020 includes interim data from a multi-center, open label, Phase I/II study in patients with T cell lymphoma (NCT03770000) with the objective of determining the MTD/optimal dose of Tenalisib given in combination with Romidepsin and assessing the preliminary efficacy of the combination. No dose limiting toxicities were reported and Tenalisib 800 mg BID plus Romidepsin 14 mg/m2 was determined to be the maximum tolerated dose for the expansion cohorts. Overall, the Tenalisib and Romidepsin combination was well tolerated across all patients (N=33) with no unexpected adverse events or increased frequency of adverse events previously reported for the individual agents.
As of the cut-off date (5th Nov 2020) for data analysis, seven PTCL patients had completed their first efficacy assessment (C3D1), of which four patients showed a complete response, one demonstrated a partial response and two had stable disease. The duration of response ranged from 1.4+ to 8.16+ months. Of the eleven CTCL patients who had completed their first efficacy assessment (C3D1), one patient showed a complete response, three demonstrated a partial response and five had stable disease. The duration of response ranged from 1.20+ to 10.6+ months.
Swaroop Vakkalanka, the company’s President and CEO stated, "We are extremely encouraged by the interim data being presented today which reinforces Tenalisib’s stellar safety and impressive efficacy when studied in combination with Romidepsin. Both PTCL and CTCL are difficult to treat indications and patients quickly run out of options, so we are excited with the preliminary results. We expect this study to eventually support a pivotal trial of the combination and we plan to approach the FDA when the full study results are available.
The Tenalisib poster session details at ASH (Free ASH Whitepaper) 2020 are noted below:
Poster Title: A Multi-Center, Open Label, Phase I/II Study to Assess the Safety and Efficacy of Tenalisib Given in Combination with Romidepsin in Patients with Relapsed/Refractory T-Cell Lymphoma (Publication Number: 1155)
Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Poster I
Date: Saturday, December 5, 2020; 7:00 AM – 3:30 PM (Pacific Time)
Presenter: Swaminathan P Iyer, MD, Professor, Department of Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX
About Tenalisib (RP 6530):
Tenalisib (RP6530) is a highly selective next generation orally active dual PI3K δ/γ inhibitor, which is in Phase 2 clinical development for hematological malignancies and solid tumors. Tenalisib has been granted US FDA Fast Track Designations for treatment of relapsed/refractory peripheral T-cell lymphoma and cutaneous T-cell lymphoma (R/R PTCL and R/R CTCL), in addition to Orphan-Drug Designations for treatment of peripheral and cutaneous T-cell lymphoma (PTCL and CTCL).
About T-Cell Lymphomas:
T-Cell Lymphomas (TCL) are a group of cancers that originate in T-cells and develop in lymphoid tissues such as the lymph nodes and spleen, or outside of lymphoid tissues (i.e., gastrointestinal tract, liver, nasal cavity, skin, and others). TCL constitute ~7-15% of all NHL cases and can be generally classified based on their presentation, as indolent or aggressive.
Peripheral T-Cell Lymphoma (PTCL) describes a heterogeneous group of lymphoproliferative disorders arising from mature T-Cells and accounts for ~10% of all NHL cases. PTCL is an aggressive disease that most commonly presents in patients over the age of 60 and usually has a worse prognosis than diffuse large B cell lymphoma.
Cutaneous T-Cell Lymphoma (CTCL) describes a group of typically indolent lymphomas that appear on, and are most often confined to, the skin and accounts for ~3% of all NHL cases and usually affects adults. CTCL subtypes include the more common and indolent Mycosis Fungoides (MF), which is largely confined to the skin, and the less common but more severe Sezary Syndrome (SS) that affects both the skin and blood and has poor prognosis.